Label: DULCOLAX LIQUID- magnesium hydroxide liquid
- NDC Code(s): 41167-0292-0
- Packager: Chattem, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated January 29, 2021
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 15 mL)
Ask a doctor before use if you have
● kidney disease
● a magnesium-restricted diet
● stomach pain, nausea or vomiting
● noticed a sudden change in bowel habits that lasts more than 2 weeks
Ask a doctor or pharmacist before use if you are
taking a prescription drug. This product may interact with certain prescription drugs.
Stop use and ask a doctor if
● you have rectal bleeding or fail to have a bowel movement after using this product. These could be signs of a serious condition.
● you need to use a laxative for more than 1 week
● shake well immediately before each use
● for accurate dosing, use convenient pre-measured dose cup
● drink a full glass (8 oz) of liquid with each dose
● dose may be taken as a single daily dose or in divided doses
● do not exceed the maximum recommended daily dose in a 24 hour period
adults and children 12 years of age and over 30 mL to 60 mL
children 6 to under 12 years of age 15 mL to 30 mL
children 2 to under 6 years of age 5 mL to 15 mL
children under 2 years of age ask a doctor
- Other information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
magnesium hydroxide liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0292 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE 1200 mg in 15 mL Inactive Ingredients Ingredient Name Strength MINT (UNII: FV98Z8GITP) MINERAL OIL (UNII: T5L8T28FGP) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) Product Characteristics Color WHITE Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41167-0292-0 354 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part334 03/01/2019 Labeler - Chattem, Inc. (003336013)